Claims (16)
1. Paliperidon palmitat, naznačen time, da je za uporabu u postupku liječenja psihoze, shizofrenije, shizoafektivnog poremećaja, shizofreniformnog poremećaja, ili bipolarnog poremećaja, pri čemu postupak obuhvaća davanje paliperidon palmitata pacijentu kojemu je to potrebno, kojemu je bila isporučena prva doza od injektibilne suspenzije paliperidon palmitata s produljenim oslobađanjem sa šestomjesečnim intervalom za doziranje (PP6M), gdje postupak obuhvaća primjenu druge doze od injektibilne suspenzije paliperidon palmitata s produljenim oslobađanjem u deltoidni ili glutealni mišić pacijenta, najviše dva tjedna prije ili tri tjedna nakon trenutka kada je prošlo šest mjeseci nakon primjene prve doze, pri čemu ne postoje interventne doze paliperidon palmitata između prve doze i druge doze,
pri čemu injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži oko 312 mg/mL paliperidon palmitata;
pri čemu je injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem vodeni pripravak koji nadalje sadrži sredstvo za suspenziju, pufer, i opcionalno jedan ili više konzervansa i sredstvo za izotonizaciju;
pri čemu prva doza sadrži oko 1092 mg paliperidon palmitata ili oko 1560 mg paliperidon palmitata; i
pri čemu druga doza sadrži oko 1092 mg paliperidon palmitata ili oko 1560 mg paliperidon palmitata.1. Paliperidone palmitate, characterized in that it is for use in the treatment of psychosis, schizophrenia, schizoaffective disorder, schizophreniform disorder, or bipolar disorder, wherein the procedure comprises the administration of paliperidone palmitate to a patient in need of it who has been delivered the first dose of an injectable paliperidone palmitate extended-release suspension with a six-month dosing interval (PP6M), where the procedure involves administering a second dose of paliperidone palmitate extended-release injectable suspension to the patient's deltoid or gluteal muscle, no more than two weeks before or three weeks after the six-month time point after administration of the first dose, where there are no intervening doses of paliperidone palmitate between the first dose and the second dose,
wherein the paliperidone palmitate extended release injectable suspension contains about 312 mg/mL paliperidone palmitate;
wherein the paliperidone palmitate extended release injectable suspension is an aqueous formulation further comprising a suspending agent, a buffer, and optionally one or more preservatives and an isotonizing agent;
wherein the first dose contains about 1092 mg paliperidone palmitate or about 1560 mg paliperidone palmitate; and
wherein the second dose contains about 1092 mg of paliperidone palmitate or about 1560 mg of paliperidone palmitate.
2. Paliperidon palmitat za uporabu prema patentnom zahtjevu 1, naznačen time, da se druga doza daje u glutealni mišić.2. Paliperidone palmitate for use according to claim 1, characterized in that the second dose is administered to the gluteal muscle.
3. Paliperidon palmitat za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da pacijent ima stabilno stanje koncentracije paliperidona u plazmi, u trenutku prve doze.3. Paliperidone palmitate for use according to patent claim 1 or claim 2, characterized in that the patient has a stable state of paliperidone concentration in the plasma, at the time of the first dose.
4. Paliperidon palmitat za uporabu prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, da se kod postupka radi o postupku za liječenje shizofrenije.4. Paliperidone palmitate for use according to any of claims 1-3, characterized in that the method is a method for the treatment of schizophrenia.
5. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da svaka od prve doze i druge doze sadrži oko 1092 mg paliperidon palmitata.5. Paliperidone palmitate for use according to any of the preceding claims, characterized in that each of the first dose and the second dose contains about 1092 mg of paliperidone palmitate.
6. Paliperidon palmitat za uporabu prema bilo kojem od patentnih zahtjeva 1-4, naznačen time, da svaka od prve doze i druge doze sadrži oko 1560 mg paliperidon palmitata.6. Paliperidone palmitate for use according to any one of claims 1-4, characterized in that each of the first dose and the second dose contains about 1560 mg of paliperidone palmitate.
7. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija paliperidona u plazmi kod pacijenta iznosi oko 5 do oko 50 ng/mL u trenutku druge doze.7. Paliperidone palmitate for use according to any one of the preceding claims, wherein the paliperidone plasma concentration in the patient is about 5 to about 50 ng/mL at the time of the second dose.
8. Paliperidon palmitat za uporabu prema patentnom zahtjevu 7, naznačen time, da kada prva doza sadrži 1092 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta iznosi oko 5 do oko 30 ng/mL u trenutku druge doze.8. Paliperidone palmitate for use according to patent claim 7, characterized in that when the first dose contains 1092 mg of paliperidone palmitate, then the concentration of paliperidone in the patient's plasma is about 5 to about 30 ng/mL at the time of the second dose.
9. Paliperidon palmitat za uporabu prema patentnom zahtjevu 7, naznačen time, da kada prva doza sadrži 1560 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta iznosi oko 9 do oko 40 ng/mL u trenutku druge doze.9. Paliperidone palmitate for use according to patent claim 7, characterized in that when the first dose contains 1560 mg of paliperidone palmitate, then the concentration of paliperidone in the patient's plasma is about 9 to about 40 ng/mL at the time of the second dose.
10. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da koncentracija paliperidona u plazmi doseže maksimum od oko 10 do oko 150 ng/mL nakon primjene druge doze.10. Paliperidone palmitate for use according to any one of the preceding claims, characterized in that the paliperidone plasma concentration reaches a maximum of about 10 to about 150 ng/mL after administration of the second dose.
11. Paliperidon palmitat za uporabu prema patentnom zahtjevu 10, naznačen time, da kada prva doza iznosi 1092 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta doseže maksimum od oko 10 do oko 125 ng/mL nakon primjene druge doze.11. Paliperidone palmitate for use according to patent claim 10, characterized in that when the first dose is 1092 mg of paliperidone palmitate, then the concentration of paliperidone in the patient's plasma reaches a maximum of about 10 to about 125 ng/mL after the administration of the second dose.
12. Paliperidon palmitat za uporabu prema patentnom zahtjevu 10, naznačen time, da kada prva doza iznosi 1560 mg paliperidon palmitata, tada koncentracija paliperidona u plazmi kod pacijenta doseže maksimum od oko 35 do oko 145 ng/mL nakon primjene druge doze.12. Paliperidone palmitate for use according to patent claim 10, characterized in that when the first dose is 1560 mg of paliperidone palmitate, then the concentration of paliperidone in the patient's plasma reaches a maximum of about 35 to about 145 ng/mL after the administration of the second dose.
13. Paliperidon palmitat za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, da injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži:
oko 312 mg/mL paliperidon palmitata;
oko 8 mg/mL do oko 12 mg/mL ovlaživača;
jedan ili više pufera;
oko 65 mg/mL do oko 85 mg/mL sredstva za suspenziju; i
vodu q.s. ad 100%.13. Paliperidone palmitate for use according to any of the preceding claims, characterized in that the injectable suspension of paliperidone palmitate with extended release contains:
about 312 mg/mL paliperidone palmitate;
about 8 mg/mL to about 12 mg/mL humectant;
one or more buffers;
about 65 mg/mL to about 85 mg/mL suspension agent; and
water q.s. ad 100%.
14. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13, naznačen time, da je suspenzija na oko pH 6,0 do oko pH 8,0.14. Paliperidone palmitate for use according to claim 13, characterized in that the suspension is at about pH 6.0 to about pH 8.0.
15. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13 ili zahtjevu 14, naznačen time, da jedan ili više pufera sadrže monohidrat limunske kiseline, natrijev dihidrogen fosfat monohidrat, bezvodni dinatrijev hidrogen fosfat, ili natrijev hidroksid.15. Paliperidone palmitate for use according to patent claim 13 or claim 14, characterized in that one or more buffers contain citric acid monohydrate, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, or sodium hydroxide.
16. Paliperidon palmitat za uporabu prema patentnom zahtjevu 13, naznačen time, da injektibilna suspenzija paliperidon palmitata s produljenim oslobađanjem sadrži:
oko 312 mg/mL paliperidon palmitata;
oko 10 mg/mL polisorbata 20; i
oko 75 mg/mL polietilen glikola 4000.16. Paliperidone palmitate for use according to patent claim 13, characterized in that the injectable suspension of paliperidone palmitate with prolonged release contains:
about 312 mg/mL paliperidone palmitate;
about 10 mg/mL polysorbate 20; and
about 75 mg/mL polyethylene glycol 4000.